Drug Labeling and Warnings

Drug Details

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ULTRACIN M- menthol gel 
Cal Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

MENTHOL (10%)

PURPOSE

TOPICAL ANALGESIC

USES

Temporarily relieves mild aches, pains, and in.ammation of muscle and joints associated with nerve damage and sport injuries.

If pregnant or breast-feeding, ask a healthcare professional before use.

WARNINGS

For external use only. Do not use on open wounds, cuts, damaged or infected skin as well as in the eye, mouth, genitals or any other mucous membrane. Stop use and consult your physican if pain is persistent or worsens.

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children over 12 years: Apply to a.ected area and gently massage over area until absorbed. Do not use more than 4 timesa day. Wash hands after gel is applied.

INACTIVE INGREDIENTS

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon,Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract, Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water

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Ultracin M copy

ULTRACIN M 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-9051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
LIME (CITRUS) (UNII: 8CZS546954)  
ALCOHOL (UNII: 3K9958V90M)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
MARITIME PINE (UNII: 50JZ5Z98QY)  
SALIX NIGRA BARK (UNII: QU52J3A5B3)  
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-9051-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/29/2012
Labeler - Cal Pharma (078721283)
Registrant - Cal Pharma (078721283)

Revised: 11/2015
 
Cal Pharma


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